JP6737829B2 - Biopsy device - Google Patents

Description

Cross-reference of related applications
[0001] This application claims the priority of US Provisional Patent Application No. 61/803,626, entitled "Improved biopsy device," filed March 20, 2013, which is incorporated by reference. Incorporated herein by reference.

[0002] The present invention relates to biopsy devices for obtaining tissue samples from human or animal tissues. The present invention is particularly, but not exclusively, directed to percutaneous biopsies, where it is desirable to achieve minimally invasive access to a suspicious mass of tissue. The present invention relates to a biopsy device that is elastic and optimal for extracting samples that are difficult to cut using conventional techniques. Further, a biopsy device optimized to deliver the highest tissue yield is disclosed.

[0003] For diagnostic purposes, it may be desirable to obtain tissue samples of the human or animal body in vitro by cytology or histology. Tissue samples can be tested for unique properties based on the diagnosis that can be made and the treatment that can be given. There are several approaches to taking tissue samples. Traditional open biopsy is increasingly being replaced by less invasive biopsy methods, especially in the field of chest biopsy, a new type of tissue extraction procedure that reduces the invasiveness of the procedure. Biopsy devices are being developed one after another.

[0004] In percutaneous techniques, needles are used to achieve less invasive access to a suspicious mass of tissue. The needle may be hollow to allow the use of vacuum to aspirate single cells and tissue debris into the lumen (suction biopsy). Alternatively, the larger tissue core has an inner movable trocar with a notch formed to receive the tissue core and an outer slide with a sharp distal end used to cut these cores from surrounding tissue. Can be harvested by a needle containing a capable cutting cannula (core needle biopsy). The tissue sample can be cut and retained within the notch by advancing the inner trocar to the suspected lesion and then advancing the outer slidable cannula to completely cover the notch. The needle can then be retracted from the patient's body and the tissue sample can be collected and stored for further analysis.

[0005] Several parameters determine whether a tissue sample is useful for analysis, one of the more important parameters is the size of the sample. Given the less invasive approach to sample extraction, the core needle is often unable to deliver a sample of sufficient size for reliable diagnosis. The use of a vacuum to engage the tissue and pull it towards the sample notch can significantly increase the size of the tissue sample for a given biopsy needle diameter. Therefore, the accuracy of diagnosis is improved. Another well known technique for increasing sample size is to take multiple samples to obtain sufficient tissue for reliable diagnosis. Biopsy systems have been developed that allow multiple samples to be extracted with a single insertion of the biopsy device, rather than multiple insertions, which is the so-called SIMS biopsy device: "Single Insert-Multiple". Samples". These devices are typically vacuum assisted and can include a tissue retrieval portion that can be moved from an advanced position at the extraction site to a retracted position where the tissue sample can be retrieved. Exemplary SIMS biopsy devices are disclosed in prior art documents WO 2006/005342, WO 2006/005343, WO 2006/005344 and WO 2006/005345, which employ a spring loaded linear cutting cannula.

[0006] In a first aspect, the present disclosure relates to a biopsy device for taking at least one tissue sample from a suspicious tissue mass within a living organism, which comprises a hollow cutting cannula, An inner member having a sharp distal tip configured to be introduced into the body and at least one sample notch for receiving a cut tissue sample, the inner member being receivable within a cutting cannula; , From a first position exposing the sample notch at the proximal end of the sample notch to a second position at the distal end of the sample notch for cutting the tissue sample from the remaining body tissue at the collection site A cutting mechanism configured to displace the cutting cannula distally in the longitudinal direction.

[0007] In an embodiment of the invention, the inner member is in a first advanced position where the sample notch of the toothed rack projects from the distal end portion of the cutting cannula and the distal end portion of the cutting cannula is referenced. As a sample notch in a proximal position to transfer at least one tissue sample from the sample notch to a second retracted position and longitudinally displaceable within the cutting cannula. A rigid and/or rotatable toothed rack. The cutting cannula and/or the toothed rack with sample notch are preferably capable of independent movement in response to a direction from the user of the biopsy device. A transport mechanism, for example in the form of an actuator system, may be provided for moving the toothed rack. The transport mechanism can include a toothed wheel configured to engage the toothed rack.

[0008] In another embodiment of the invention, the inner member forms a hollow needle, wherein a biopsy device proximally cuts the cut tissue sample inside the hollow needle from a sample notch to a retrieval position. At the collection position, configured for longitudinal displacement, the tissue sample may be collected in a tissue collection tank, for example transferred into the tissue collection tank. This longitudinal displacement can be performed by a vacuum supplied through the hollow needle.

[0009] The biopsy device according to the present invention is preferably adapted to be hand-held by a user when taking a tissue sample.
[0010] A further embodiment of the invention relates to a disposable unit for a biopsy device for taking at least one tissue sample from a suspicious tissue mass in the body of a living organism, which unit comprises a hollow cutting cannula and a cutting cannula. An inner member comprising a sharp distal tip configured to be introduced into the body and at least one sample notch for receiving a cut tissue sample, the inner member being receivable within a cutting cannula. And a second position from the first position to expose the sample notch at the proximal end of the sample notch to cut the tissue sample from the remaining body tissue at the collection site. Up to and including a cutting mechanism configured to displace the cutting cannula distally in the longitudinal direction. The disposable unit may further comprise an interface for connecting the disposable unit to the handle unit.

The present invention will be described in more detail with reference to the drawings.

[0012] FIG. 3 illustrates an exemplary embodiment of a biopsy device according to the present invention. [0013] FIG. 2 is an exploded view of the components of FIG. [0014] FIG. 4 is a detailed view of a rigid toothed rack with a sharp tip and sample notch at the distal end and a rotation zone in the proximal end. [0015] Figure 4a shows the cutting cannula in an advanced position over the sample notch. [0016] Figure 4b shows the cutting cannula in a retracted position exposing the sample notch. [0017] FIG. 7 illustrates a damper spring for use in connection with the passage of a spring loaded cutting cannula. [0018] FIG. 6 illustrates a counter-rotating cutting interface between a sample notch and a cutting cannula. [0019] FIG. 10 is a cross-sectional view of a cutting cannula featuring a longitudinal air channel with lateral vents. [0020] Figure 8a is a diagram showing a tissue recovery tank. [0021] Figure 8b is a cutaway view of the tissue recovery tank of Figure 8a. [0022] FIG. 6 illustrates a cutting interface between a cutting cannula and a protrusion at an inner member that forms a cutting board for the cutting cannula. The cutouts in the drawings show the longitudinal air channels and multiple vents in the cutting cannula.

[0023] Corresponding reference characters indicate corresponding parts throughout the several views. The illustrations provided herein show embodiments of the invention and are not to be construed as limiting the scope of the invention in any way.

[0024] The drawings show an exemplary biopsy device equipped with a needle portion with a cutting cannula 1, 1', and a sample notch 3 with a sharp distal tip 4 for penetrating tissue. Cutting cannula 1 has a sloping cutting profile, as shown, for example, in FIGS. 2 and 6, whereas cutting cannula 1'has a straight cutting profile 24, as shown, for example, in FIGS. 5, 7 and 9. The sample notch 3 is part of the rigid toothed rack 2 and is movable between a first advanced position and a second retracted position when actuated by a suitable source of mechanical motion. .. The source of mechanical motion may be a battery powered motor, which may be operably connected to the rigid toothed rack 2 by one or more gear wheels 11.

[0025] An operable connection between the rigid toothed rack 2 and the gear wheel 11 is to rotate the toothed rack 2 completely 360 degrees about its longitudinal axis, including the sample notch 3. Configured to enable. Such rotation may be possible, for example, by providing a proximal rotation zone 12 with a series of cutouts extending around the entire circumference of the toothed rack. A rotation control gear 9 is operably connected to the rigid toothed rack to rotate the rigid toothed rack 2 about its longitudinal axis. gear) 10. A separate set of gear wheels is provided to allow the cutting cannula 1 to be fully rotated 360 degrees, independently of the rotation of the rigid toothed rack 2 or in response to the rotation of the rigid toothed rack 2. It may be operably engaged with the cutting cannula 1.

[0026] The cutting cannula 1, 1'can be retracted when actuated by a suitable source of mechanical motion. In the first embodiment, the source of mechanical motion is a second motor powered by a battery and operably connected to the cutting cannula 1, 1'by a series of gears driving an actuator rod. You can Retracting the cutting cannula 1, 1'exposes the sample notch 3, 3', which allows tissue to escape into the lateral opening of the sample notch 3, 3'.

[0027] A vacuum may be switched on to assist in escaping the tissue into the sample notch 3, 3'when or after retracting the cutting cannula 1, 1'. Vacuum is communicated from the vacuum pump and hose through a vacuum gasket 7 operably connected to the cutting cannula 1, 1'and into the inner lumen of the cutting cannula 1, 1'. The rigid toothed rack 2 is equipped with at least one vacuum cutout 16 extending along the length of the rigid toothed rack 2 and terminating at the sample notch 3 so that as soon as the pump is activated, the vacuum is cut off. The vacuum from the pump is communicated through these vacuum cutouts 16 to the sample notch 3.

[0028] A vacuum accumulator/reservoir may be configured to generate and store a vacuum, and may also be in fluid communication with the sample notches 3, 3'to increase the size of the sample with a cutting cannula 1, 1'. The vacuum strength can be temporarily boosted just prior to firing.

[0029] By retracting the cutting cannula 1, 1', a spring-loaded starter mechanism that can power the cutting cannula forward (ie, distally) at high speed is pulled back. As the cutting cannula 1, 1 ′ moves forward at high speed, the sharp distal end of the cannula 1, 1 ′ contacts the tissue that has prolapsed into the sample notch 3, 3 ′ and bonds the tissue to the surrounding bond. Disconnect from the connecting tissue.

[0030] As shown in FIG. 5, the cutting cannula 1'may be able to continue its movement by means of a damper spring 13 arranged in a damper spring housing 14, with a rear flange 15 of the cutting cannula 1'. Operatively connected. Due to the inertia of the cutting cannula 1', it is possible to advance the cutting cannula 1'by 1 to 2 mm beyond the permissible movement distance of the spring type starting mechanism, and the inertia of the cutting cannula 1'also enables the cutting cannula 1'. It ensures that the sharp distal end of 1'overlaps properly with the distal section of the sample notch 3'. After overthrow, the damper spring 13 ensures that the cutting cannula 1'returns to its neutral position and is ready for the next tissue sample.

[0031] As shown in FIG. 6, the user of the biopsy device references the fixed cutting cannula 1 to cut any connective tissue that has not been completely cut by the cutting cannula 1. As, there is the option of rotating the toothed rack 2 with the sample notch 3. Connected tissue that is not completely dissected can limit the retraction of the tissue sample and can be painful to the patient. The rotation causes the not fully cut connective tissue to be sawed by the sharp distal end of the cutting cannula 1 for the required time, thereby completing the cut. The rotation can be stepwise, can switch between clockwise and counterclockwise directions, and can take a rotation angle of, for example, +/−20 degrees with respect to the neutral position. Furthermore, the cutting cannula 1 can be retracted and advanced in steps of 1-2 mm during rotation, which can further aid in cutting tissue. When the sample notch 3 returns to the state of being able to move without limitation, the toothed rack 2 can continue its motion from the first forward position to the second retracted position, whereby the sample notch 3 Tissue sample is transported out of the patient's body.

[0032] The tissue sample may be collected in a tissue collection tank 8 that includes a vacuum spout 21, through which vacuum from a vacuum pump or vacuum accumulator may be communicated into the collection tank chamber 22. A vacuum from the collection tank chamber is communicated through the tissue collection spout 23 to improve collection of the tissue sample. As shown in FIG. 8 b, a collection spout 23 forms a collection tube 23 ′ inside the collection tank 22 that extends a certain length from the bottom of the tank 22. After collection of the tissue sample from the sample notch 3, the sample notch 3 can be returned to the extraction site for collection of the next tissue sample.

[0033] As shown in FIGS. 7 and 9, the cutting cannula may have an inner tube 17 and an outer tube 18, forming a longitudinal air channel 19 therebetween,
The longitudinal air channel 19 is in fluid communication with the first vacuum pump at the proximal end through a two-way valve that can be switched between a vacuum position and a position that allows ambient air to enter the air channel. To be done. At the distal end, an air channel 19 is in fluid communication with the lateral opening of the sample notch 3 through at least one vent 20 formed in the inner tube 17.

[0034] As shown in FIG. 9, the plurality of vent holes 20 may be circumferentially distributed around the interior of the inner tube 17. As shown in FIG. 9, a protrusion 25 formed as a collar is provided adjacent the sharpened distal end 4'. The interface 26 between the protrusion 25 and the cutting cannula 1'forms a cutting board to ensure that the connective tissue is cut properly during cutting.

[0035] One problem frequently encountered when taking tissue samples is the presence of fibrous or connective tissue. Such a tissue has a high elasticity and is characterized by being difficult to cut. A typical symptom of connective tissue related dysfunction is that the biopsy device becomes clogged in the patient's body and needs to be removed by forceful or surgical intervention. This can be negative for both the physician and the patient, and can also cause the patient great pain. Inappropriately cut connective tissue is a known problem for all types of biopsy devices, which is highly undesirable.

[0036] In order to use a straight cutter when properly cutting connective tissue, very precise interaction between the sharp distal end of the cutting cannula and the distal section of the sample notch is required. Need. For this reason, it is important that the position of the sample notch be very accurately controlled with respect to the position of the cutting cannula. SIMS devices featuring a linear spring cutting cannula typically employ a sample notch that is attached to a flexible bendable elongate member (eg, a non-rigid toothed rack), the toothed rack comprising: Depending on the flexibility, design and materials chosen, it is not always necessary to control the position of the sample notch as desired. Some prior art devices employ toothed racks made of thermoplastic elastomers that have great elasticity in the longitudinal direction. Having a sample notch in a rigid toothed rack that is inelastic in the longitudinal direction improves position control. This allows the sharp end of the cutting cannula to properly overlap the distal section of the sample notch. Failure to establish the exact position of the sample notch can result in imperfect closing of the sample notch opening. The rigid toothed rack provides the necessary lateral inelasticity and stability, which ensures that the sharp distal end of the cutting cannula completely closes the sample notch opening. Thus, employing a rigid toothed rack improves control of the longitudinal and lateral position of the sharpened distal end of the cutting cannula relative to the distal section of the sample notch.

[0037] In one embodiment, the proximal end of the rigid toothed rack is configured to be operably connected to the retraction gear wheel, and further comprises disconnecting the operative connection with the retraction gear wheel. It is configured to allow the toothed rack to be rotated 360 degrees about its longitudinal axis without need. This may be possible due to the rotating mechanism.

[0038] In a further embodiment of the invention, the rigid toothed rack comprises a circumferential zone at the proximal end comprising circumferential teeth extending around the entire circumference of the toothed rack, for example in the form of a series of cutouts. With which it is possible to rotate the rigid toothed rack. The rigid toothed rack may be rotatable within the cutting cannula and/or the rigid toothed rack, the cutting cannula being simultaneously rotatable with respect to the biopsy device. The allowable rotation can be 360 degrees. The biopsy device may further comprise a rotation control gear mounted on the rigid toothed rack. A rotary drive gear may be provided, which rotary drive gear may be configured to engage a rotary control gear to rotate the rigid toothed rack. The cutting cannula may also be configured to rotate about its longitudinal axis, such as 360 degrees.

[0039] In a further embodiment of the invention, the rigid toothed rack is only capable of longitudinally displacing the rigid toothed rack to a second retracted position in a predetermined rotational orientation of the rigid toothed rack. Configured to be broken. Accordingly, the rigid toothed rack may be rotatable within the cutting cannula only in the first advanced position, and/or the rigid toothed rack and cutting cannula may only be in the first advanced position. Can be rotated at the same time.

[0040] Whether the rigid toothed rack and/or the cutting cannula are rotated simultaneously or independently is determined by an interlocking mechanism configured to secure the rigid toothed rack and cutting cannula to each other. It can be at least partially controlled. For example, the interlocking mechanism can have two states, one allowing the cutting cannula and the toothed rack to move freely with respect to each other, and the other with the two of them relative to each other. Fix it.

[0041] This may help ensure that the sample notch is always reliably and accurately oriented with respect to the tissue recovery tank when transferring the tissue sample to the tissue recovery tank. This may be possible if the teeth of the toothed rack are on only one side of the rigid toothed rack. If the proximal rotation zone of the toothed rack mentioned above is present, the teeth extending distally beyond the rotation zone are located on only one side of the rigid toothed rack. A control system can help ensure that the rigid toothed rack is rotationally oriented correctly before retracting to the retracted position.

[0042] When cutting a tissue sample, it may be advantageous to rotate the rigid toothed rack with respect to the cutting cannula (or vice versa), which may improve the cutting mechanism. By rotating the toothed rack with respect to the cutting cannula with the sharp distal end, and thus also by rotating the sample notch, a "sewing" motion can be produced, which is a partially cut. Cutting the connective tissue that has been done can be completed. Furthermore, the cutting cannula and the rigid toothed rack can be counter-rotated during cutting, which makes it possible, for example, to improve cutting of connective tissue.

[0043] Thus, in one embodiment of the invention, the rigid toothed rack is rotatable within the cutting cannula when cutting at least one tissue sample. The cutting mechanism may be configured to rotate the rigid toothed rack within the cutting cannula when cutting at least one tissue sample. The rotation may be stepwise or continuous. The rigid toothed rack and/or cutting cannula may be rotatable in clockwise and/or counterclockwise directions. The rotation angle of the rigid toothed rack relative to the cutting cannula during cutting is between -5 and +5 degrees, more preferably between -10 and +10 degrees, and more preferably between -15 and +15 degrees. Degrees, more preferably between -20 and +20 degrees, more preferably between -25 and +25 degrees, and more preferably between -30 and +30 degrees, that is, It behaves like a sawing motion that oscillates between clockwise and counterclockwise directions.

[0044] When performing a biopsy, it is often necessary to rotate the entire biopsy device inside the patient to place the sample notch in contact with the suspicious tissue mass. This may deteriorate the operating environment when collecting a tissue sample. Thus, a further advantage of being rotatable is that the rigid toothed rack and cutting cannula are preferably controlled by the user to rotate simultaneously about their longitudinal axes relative to the biopsy device. It is possible, for example, to orient the sample notch towards the suspected mass of tissue before activating the triggering mechanism. Thus, the biopsy device can be held in a fixed position while rotating the rigid toothed rack and cutting cannula to the correct angular orientation relative to the suspect mass of tissue.

[0045] Another method for improving the accurate cutting of tissue is configured so that the cutting mechanism is replaceably retracted and advanced in small longitudinal steps during cutting of the tissue sample. Is Rukoto. The size of these steps may be between 0 mm and 3 mm, between 0 mm and 1 mm, between 1 mm and 2 mm, or between 2 mm and 3 mm. This corresponds to the longitudinal sawing motion.

[0046] The cutting mechanism may also be improved by being configured to overlap and/or pass in a predetermined manner when cutting a tissue sample, such that the distal end of the cutting cannula is at the second position. To temporarily pass over the distal end of the sample notch before returning to the position. The length of said passage is between 0.5 mm and 5 mm, between 0.5 mm and 1 mm, between 1 mm and 2 mm, between 2 mm and 3 mm, between 3 mm and 4 mm, or between 4 mm and 5 mm. You can This passage through the cutting cannula can help to further stress tissue that is not completely cut. The passage can be performed by an elastic element provided in connection with the cutting cannula. One solution may be in the form of at least one damper spring installed within the damper spring housing. Damping can also be done by using a damping element in the form of rubber. The elastic element may be configured to work with the triggering mechanism of the cutting cannula, which is done when cutting the tissue sample. When the starting mechanism is stopped by the elastic element, the inertia of the cutting cannula and the elasticity of the elastic element allow the sharp end of the cutting cannula to be advanced at a constant distance beyond the travel of the spring-loaded starting mechanism, It ensures that the sharp distal end of the cutting cannula properly overlaps the distal section of the sample notch. The elastic element ensures that the cutting cannula returns to its neutral position after this passage and is ready for the next tissue sample.

[0047] As an alternative to, or as a complement to, the overlap or passage between the sharp distal end of the cutting cannula and the distal section of the sample notch, an inner member is provided between the sharp distal end and the sample notch. There may further be located a circumferential circumferential protrusion and/or collar, said circumferential protrusion being formed to fit the distal end of the cutting cannula. Thus, the circumferential protrusion may be configured to form a cutting surface for a cutting cannula when cutting a tissue sample. A cutting board (protrusion) may be placed around the outer perimeter of the sample notch and serves the purpose of ensuring that the cutting cannula cuts the tissue sample completely cleanly. The cutting mechanism may be configured to bring the cutting cannula and the circumferential protrusion into contact when cutting the tissue sample. Thus, the protrusion is preferably formed of a softer material than the cutting cannula so as to maintain the sharpness of the cutting cannula without blunting the cutting cannula. The cutting mechanism may alternatively be configured such that the cutting cannula and the circumferential protrusion are not in contact when cutting the tissue sample. In this case, the circumferential protrusions can be brought into close proximity without contact when cutting the tissue sample. That is, direct physical contact between the protrusion and the sharp distal end of the cutting cannula is avoided, but the material surface is in the immediate vicinity of said sharp distal end. In cases where such protrusions are used, the tissue sample must be transported through the interior of the inner member, typically by vacuum, if SIMS functionality is desired.

[0048] In another embodiment of the invention, the cutting cannula comprises at least one longitudinal vacuum channel (also referred to as longitudinal air channel or passage) formed within the outer shell/wall of the cutting cannula. .. The longitudinal vacuum channels may be circumferential. The air channel may be provided by forming the cutting cannula as an inner tube and an outer tube defining an air passageway extending longitudinally along the length of the inner tube and the outer tube. Fluid communication from the air channel to the inner lumen of the cutting cannula may be achieved by one or more lateral vents extending from the interior of the cutting cannula to the longitudinal air channel. The plurality of lateral vents may be circumferentially distributed within the cutting cannula. In this case, the longitudinal vacuum channel may be in fluid communication with the sample notch at its distal end when the rigid toothed rack is in its first advanced position. Thus, the cutting cannula may be configured to be able to provide and/or establish a vacuum or air flow inside the cutting cannula, for example to provide air flow from the air channels into the inner lumen of the cutting cannula. Fluid communication from this air channel to the exterior of the cutting cannula can be achieved by at least one vacuum spout and can be controlled by at least one vacuum valve. Furthermore, a vacuum pump can be connected to the air channel via this vacuum valve, in which case a vacuum can be communicated through the air channel and the air vents into the inner lumen of the cutting cannula. Therefore, air may be sucked out from the inner lumen of the cutting cannula. Such evacuation can be useful in reducing or eliminating problems such as inadvertently entering air into the biopsy cavity and disturbing the image quality of the ultrasound guided biopsy procedure. There is a nature. When advancing the rigid toothed rack from the second retracted position to the first advanced position, unwanted air can enter the cavity for biopsy. This advancement of the rigid toothed rack inside the cutting cannula can act as a piston to compress the air inside the cutting cannula, but this air is eventually pumped into the cavity for biopsy. Will disturb the ultrasonic image. Evacuation of air from the cutting cannula through the longitudinal vacuum channels inside the sidewalls of the cutting cannula as the rigid toothed rack is advanced can address and solve this problem.

[0049] A further embodiment of the present invention comprises a tissue collection tank for collecting at least one tissue sample transferred from the sample notch. The tank can include a tissue collection spout that can be configured to slide into the sample notch chamber to scoop the tissue sample into the sample tank. To improve the recovery of the tissue sample, the tissue recovery tank may be configured to be evacuated, for example by connecting to a vacuum pump via a vacuum port at the tank. The collection spout may be elongated to form a pipe (also referred to as a collection pipe) to improve collection of the tissue sample into the tank with the aid of vacuum. Outside, the collection spout/pipe forms a small spout, but inside the tissue collection tank, the collection pipe extends to and/or projects into the tissue collection tank, that is, the collection pipe is inside the tissue collection tank. It may protrude from the bottom or sides. Therefore, the recovery pipe has a fixed length inside the tissue recovery tank. This length of the recovery pipe is at least 2 mm, at least 4 mm, at least 6 mm, at least 8 mm, at least 10 mm, at least 12 mm, at least 14 mm, at least 16 mm, at least 18 mm, at least 20 mm, at least 22 mm, at least 24 mm, at least 26 mm, at least 28 mm, It may be at least 30 mm, at least 32 mm, at least 34 mm, at least 36 mm, at least 38 mm, or at least 40 mm.

[0050] Some biopsy devices are always connected to an external vacuum pump via an external vacuum hose. Although these pumps can provide a strong and constant vacuum to the biopsy device, the required vacuum hose reduces the maneuverability of the biopsy device to the user. One conventional solution to this problem has been to provide one or more battery-operated local small vacuum pumps integrated into the biopsy device. However, such small vacuum pumps can only provide a limited amount of air flow, which is sometimes insufficient to maintain a constant vacuum level. The solution to this problem may be a vacuum reservoir integrated in the biopsy device, which is capable of supplying a boost to the (negative) air flow for one or more short periods of time, and thus a vacuum reservoir This additional air flow provided by can maintain a constant vacuum level. In this case, the biopsy device may be equipped with one or more small vacuum pumps, optionally supplied by a vacuum reservoir. Accordingly, another embodiment of the present invention is a vacuum reservoir (vacuum accumulator) configured to accumulate a certain amount of vacuum that may be delivered as a temporary boost to the air flow to maintain the vacuum level found in the system. Also referred to as). Such a vacuum reservoir may be powered by a battery, for example. A vacuum reservoir may be in fluid communication with the sample notch and may be configured to increase suction to maintain a vacuum level within the sample notch when cutting a tissue sample, such as immediately prior to releasing the cutting cannula, The amount of tissue that escapes into the sample chamber can be increased, thereby maximizing the size of the tissue sample cut. The vacuum reservoir may also be in fluid communication with the interior of the hollow inner member and may be configured to provide a temporary boost of air flow as the tissue sample is drawn through the inner member. Additionally, the vacuum reservoir may be in fluid communication with the tissue collection tank, providing a vacuum to the tissue collection tank to maintain a vacuum level when transferring the tissue sample from the sample notch into the tissue collection tank, or the tissue collection tank. Configured to increase the suction force of the. The vacuum reservoir can have a volume of 5-100 mL, 5-10 mL, 10-20 mL, 20-30 mL, 30-40 mL or 50-100 mL.

[0051] Retracting the cutting cannula to expose the sample notch may be performed, for example, by a motor powered by a battery and connected to one or more gear wheels, but with another power source and Mechanical actuation means are also envisaged. Retracting the cutting cannula in this manner may facilitate pulling back the starting mechanism, which may be spring loaded, for example. Alternative triggering mechanisms may also be provided including electrical, pneumatic and chemical mechanisms. Having the cutting cannula perform the cutting action when actually cutting the tissue can be powered by energy stored in the starter mechanism, which is a high speed linear across the lateral opening of the sample notch. It is done as an exercise. As it passes in this way, the sharp distal end of the cutting cannula contacts the tissue that has prolapsed into the sample notch chamber to cut those tissues from the surrounding tissue, thereby allowing the tissue sample to enter into the sample notch. Is obtained. The firing mechanism may be replaced with a linear actuator that allows the cutting cannula to be controlled and advanced during cutting. In this case, the advancement of the cutting cannula becomes more controlled, and as explained above, it may be desirable to rotate the cutting cannula during advancement in order to adequately cut the tissue.

[0052] To provide for SIMS functionality, the sample notch can be retracted by a motor operably connected to the rigid toothed rack by one or more gear wheels. At start-up, the motor moves the rigid toothed rack and sample notch from the first forward position to the second retracted position, where the sample may be retrieved by, for example, a tissue recovery tank, Other collection means may also be envisaged, including manual collection and the like. After completing the collection of the sample, the sample notch can be returned to the extraction site by reversing the direction of rotation of the motor.

[0053] The triggering mechanism may be configured to displace the cutting cannula and the inner member distally in the longitudinal direction, where, at the time of sampling, at or near the suspicious tissue mass prior to the cutting operation. At the cutting cannula and inner member penetrate the body tissue.

[0054] In one embodiment of the invention, the inner member comprises a vacuum port in fluid communication with the sample notch. Therefore, the inner member may be configured to allow the sample notch to be evacuated. A vacuum pump may be provided for creating a suction effect within the sample notch for the purpose of increasing the size of the tissue sample that escapes into the sample notch, the vacuum pump extending longitudinally within the inner member. Is in fluid communication with the sample notch through a channel.

[0055] A further embodiment of the invention comprises a handle unit comprising a power source for driving the cutting mechanism and for displacing the inner member and at least one motor, wherein at least the cutting cannula and the inner member are , A disposable unit that is detachably fixed to the handle unit.

[0056] To ensure that the cutting cannula and sample notch overlap to a sufficient extent to cleanly cut the tissue to be extracted, the cutting cannula is preferably characterized by very tight length tolerances. And Such tolerances can be achieved by using a material with a low creep deformation that is machined using high precision milling or forming, and the possible total length variation is the Depending on the total length of the cannula, it will be +/-0.5 mm or less. The preferred material for the cutting cannula is stainless steel made as a tube. These tubes are typically made by rolling and welding sheet metal to form a tubular structure and drawing the tubular structure through a tool with diamond inserts to a desired diameter. The drawing process may be employed multiple times in order to obtain high accuracy. The use of stainless steel allows for low creep deformation of the cutting cannula, eliminating or minimizing elongation, and achievable manufacturing tolerances. Other materials, including titanium, are also envisioned for making the cutting cannula.

[0057] To further assist in properly overlapping the cutting cannula and sample notch, the rigid toothed rack may also be characterized by very tight length tolerances. Such tolerances, in some embodiments, may be achieved by using low creep deformation materials that are machined using high precision milling or molding, and the possible total length variation is: Depending on the total length of the rigid toothed rack, it will be +/-0.5 mm or less. The preferred material for the rigid toothed rack is stainless steel. Rigid toothed racks are usually made by milling a turned stainless steel metal rod into the desired geometry. Another suitable material for rigid toothed racks is titanium or similar metal, which has a high modulus of elasticity. Alternative materials include thermoplastic elastomers with suitable fillers to improve the modulus of elasticity. A suitable type of rigid toothed rack is LCP (Liquid Crystal Polymer), PEEK (polyether ether ketone) of any grade. Thermoplastic elastomers have the advantage of being relatively easy to process and manufacture, but they are less rigid than metals and are more prone to creep deformation and shrink than metals.

[0058] Although the present invention has been described in connection with at least one embodiment, the present invention can be further modified within the spirit and scope of the disclosure. Accordingly, this application is intended to cover any variations, uses, or adaptations of the invention that use the general principles of the invention. Moreover, this application is intended to cover any departures from this disclosure that are within the scope of known or conventional practices of the invention to which this invention pertains, and within the scope of the appended claims. To be done.
As described above, the present invention has the following modes.
[Form 1]
A biopsy device for taking at least one tissue sample from a suspicious mass of tissue in the body of a living organism, comprising:
A hollow cutting cannula,
An inner member comprising a rotatable toothed rack having a sharp distal end configured to be introduced into the body and a sample notch for receiving the at least one severed tissue sample, the cutting comprising: An inner member that can be received within the cannula,
A second position at a distal end of the sample notch from a first position exposing the sample notch at a proximal end of the sample notch for cutting the tissue sample from remaining body tissue at a collection site. A biopsy device configured to displace the cutting cannula distally in the longitudinal direction up to a position.
[Form 2]
A first advanced position in which the rotatable toothed rack is a rigid toothed rack and the inner member projects the sample notch of the rigid toothed rack from the distal end portion of the cutting cannula. And a second retraction where the sample notch can be positioned in a proximal position relative to the distal end portion of the cutting cannula to transfer the at least one tissue sample from the sample notch. The biopsy device of Form 1, which is longitudinally displaceable within the cutting cannula between positions.
[Form 3]
The inner member is a hollow needle and the biopsy device is configured to displace the cut tissue sample within the hollow needle in a proximal direction in the longitudinal direction from the sample notch to a retrieval position; The biopsy device of form 1, wherein at the collection location, the tissue sample can be transferred into a tissue collection tank.
[Form 4]
The biopsy device according to aspect 3, wherein the longitudinal displacement is performed by a vacuum supplied through the hollow needle.
[Form 5]
The biopsy device according to any one of aspects 1 to 4, wherein the rotatable toothed rack includes a rotation zone with circumferential teeth in the proximal end.
[Form 6]
The biopsy device according to any one of aspects 1 to 5, further comprising a rotation control gear attached to the rotatable toothed rack.
[Form 7]
7. The biopsy device of aspect 6, further comprising a rotary drive gear configured to engage the rotation control gear to rotate the rotatable toothed rack.
[Form 8]
8. The biopsy device according to any one of aspects 1-7, further comprising an interlocking mechanism configured to secure the rotatable toothed rack and the cutting cannula to each other.
[Form 9]
9. The biopsy device according to any one of Forms 1-8, wherein the rotatable toothed rack is rotatable within the cutting cannula.
[Form 10]
The biopsy device according to any one of aspects 1-9, wherein the rotatable toothed rack is rotatable within the cutting cannula only in the first advanced position.
[Form 11]
11. The biopsy device according to any one of aspects 1-10, wherein the rotatable toothed rack and the cutting cannula are simultaneously rotatable with respect to the biopsy device.
[Form 12]
12. The biopsy device according to any one of aspects 1 to 11, wherein the rotatable toothed rack and the cutting cannula are simultaneously rotatable relative to the biopsy device only in the first advanced position. ..
[Mode 13]
13. The biopsy device according to any one of Forms 9-12, wherein the rotation of at least one of the rotatable toothed rack and the cutting cannula is stepwise.
[Form 14]
14. The biopsy device according to any one of aspects 9 to 13, wherein at least one of the rotatable toothed rack and the cutting cannula is rotatable in a clockwise or counterclockwise direction.
[Form 15]
15. The biopsy device according to any one of aspects 1-14, wherein the rotatable toothed rack is rotatable within the cutting cannula when cutting the at least one tissue sample.
[Mode 16]
16. The raw according to any one of Forms 1 to 15, wherein the cutting mechanism is configured to rotate the rotatable toothed rack within the cutting cannula when cutting the at least one tissue sample. Inspection device.
[Form 17]
17. The biopsy device according to any one of Forms 15 to 16, wherein the rotation oscillates between clockwise and counterclockwise directions.
[Form 18]
18. The biopsy device according to any one of Forms 15 to 17, wherein the rotation is stepwise.
[Form 19]
The rotation angle of the rotatable toothed rack with respect to the cutting cannula being cut is between -5 degrees and +5 degrees, more preferably between -10 degrees and +10 degrees, and more preferably -15 degrees. Form 15 which oscillates between 1 and +15 degrees, more preferably between -20 degrees and +20 degrees, more preferably between -25 degrees and +25 degrees, and more preferably between -30 degrees and +30 degrees. The biopsy device according to any one of claims 1 to 18.
[Form 20]
20. The biopsy of any one of Forms 1-19, wherein the cutting mechanism is configured to replaceably retract and advance the cutting cannula in small longitudinal steps when cutting a tissue sample. device.
[Form 21]
21. The biopsy device according to aspect 20, wherein the step size is between 0 mm and 3 mm, between 0 mm and 1 mm, between 1 mm and 2 mm, or between 2 mm and 3 mm.
[Form 22]
The rotatable toothed rack is configured such that it can only be displaced longitudinally in the predetermined rotational orientation of the rotatable toothed rack to the second retracted position. 22. The biopsy device according to any one of forms 5 to 21.
[Form 23]
23. The biopsy device according to any one of aspects 5 to 22, wherein the tooth portion is located only on one side of the rotatable toothed rack.
[Mode 24]
The form according to any one of aspects 5 to 23, wherein the tooth portion extending in the distal direction beyond the rotation zone of the rotatable toothed rack is located only on one side of the rotatable toothed rack. Biopsy device as described.
[Form 25]
The inner member further comprises a circumferential protrusion located between the sharp distal end and the sample notch, the circumferential protrusion being formed to fit the distal end of the cutting cannula. 25. The biopsy device according to any one of forms 1 to 24.
[Form 26]
26. The biopsy device according to form 25, wherein the protrusion is formed of a softer material than the cutting cannula.
[Form 27]
27. The biopsy device of any one of Forms 25-26, wherein the circumferential protrusion is configured to form a cutting surface for the cutting cannula when cutting a tissue sample.
[Form 28]
28. The biopsy device of any one of aspects 25-27, wherein the cutting mechanism is configured such that the cutting cannula and the circumferential protrusion contact when cutting a tissue sample.
[Form 29]
28. The biopsy device according to any one of aspects 25-27, wherein the cutting mechanism is configured such that the cutting cannula and the circumferential protrusion are not in contact when cutting a tissue sample.
[Form 30]
28. The form according to any one of aspects 25 to 27, wherein the cutting mechanism is configured to feed the cutting cannula and the circumferential protrusion in the immediate vicinity without contact when cutting a tissue sample. Biopsy device.
[Form 31]
The cutting mechanism is configured to pass in a predetermined manner when cutting a tissue sample, such that the distal end of the cutting cannula temporarily moves the sample notch before returning to the second position. 31. The biopsy device of any one of Forms 1-30, which is adapted to pass beyond the distal end of the.
[Form 32]
The length of said passage is between 0.5 mm and 5 mm, between 0.5 mm and 1 mm, between 1 mm and 2 mm, between 2 mm and 3 mm, between 3 mm and 4 mm, or between 4 mm and 5 mm. A biopsy device according to Form 31.
[Form 33]
33. The biopsy device of any one of Forms 31-32, wherein the cutting mechanism comprises an elastic element connected to the cutting cannula and configured to perform the passage.
[Form 34]
34. The biopsy device according to aspect 33, wherein the elastic element comprises at least one damper spring located within a damper spring housing.
[Form 35]
34. The biopsy device according to form 33, wherein the elastic element comprises at least one damping element formed of rubber.
[Form 36]
36. The biopsy device according to any one of Forms 1 to 35, wherein the cutting cannula comprises at least one longitudinal vacuum channel formed within an outer shell of the cutting cannula.
[Form 37]
37. The biopsy device of any one of Forms 1 to 36, wherein the cutting cannula is configured to provide a vacuum inside the cutting cannula.
[Form 38]
38. The biopsy device according to any of configurations 36-37, wherein the longitudinal vacuum channel is circumferential within the outer shell of the cutting cannula.
[Form 39]
39. The biopsy device according to any of configurations 36-38, wherein the longitudinal vacuum channel is in external fluid communication at its proximal end to the exterior of the cutting cannula.
[Form 40]
40. The biopsy device according to aspect 39, wherein the external fluid communication is achieved by at least one vacuum spout and controlled by at least one vacuum valve.
[Form 41]
41. The biopsy device of any of configurations 36-40, wherein the longitudinal vacuum channel is in fluid communication at its distal end with the interior of the cutting cannula.
[Form 42]
42. The configuration of any one of aspects 36-41, wherein the longitudinal vacuum channel is in fluid communication at its distal end with the sample notch when the toothed rack is in its first advanced position. Biopsy device.
[Form 43]
43. The biopsy device according to any of configurations 41-42, wherein the fluid communication is achieved by one or more lateral vents extending from the interior of the cutting cannula to a longitudinal air channel.
[Form 44]
44. The biopsy device according to aspect 43, comprising a plurality of the lateral vents circumferentially distributed within the cutting cannula.
[Form 45]
45. The biopsy device of any one of aspects 1-44, further comprising a tissue recovery tank for recovering the at least one tissue sample transferred from the sample notch.
[Form 46]
46. The biopsy device according to aspect 45, wherein the tissue collection tank is configured to be evacuated.
[Form 47]
47. The form 45-46, wherein the tissue collection tank is configured to be evacuated to facilitate transfer of a tissue sample from the sample notch or the like into the sample collection tank. Biopsy device.
[Form 48]
48. The biopsy device of any one of aspects 45-47, wherein the tissue collection tank further comprises a vacuum port for providing a vacuum inside the tissue collection tank.
[Form 49]
48. The biopsy device of any of aspects 45-47, wherein the tissue collection tank further comprises a collection pipe configured to transfer a tissue sample from the sample notch into the sample collection tank.
[Form 50]
50. The biopsy device of form 49, wherein the recovery pipe extends to and/or projects into the tissue recovery tank.
[Form 51]
51. The biopsy device according to any of configurations 49 to 50, wherein the recovery pipe projects from a bottom or side inside the tissue recovery tank.
[Form 52]
52. The biopsy device according to any of forms 49 to 51, wherein the recovery pipe has a length within the tissue recovery tank.
[Form 53]
The length of the recovery pipe is at least 2 mm, at least 4 mm, at least 6 mm, at least 8 mm, at least 10 mm, at least 12 mm, at least 14 mm, at least 16 mm, at least 18 mm, at least 20 mm, at least 22 mm, at least 24 mm, at least 26 mm, at least 28 mm, 53. The biopsy device according to any one of forms 49 to 52, which is at least 30 mm, at least 32 mm, at least 34 mm, at least 36 mm, at least 38 mm, or at least 40 mm.
[Form 54]
Forms 1 through 53, further comprising a vacuum reservoir configured to accumulate a constant amount of vacuum that can be supplied as a temporary boost to the air flow and/or maintain the vacuum level found in the system. The biopsy device according to any one of claims.
[Form 55]
55. The biopsy device according to aspect 54, wherein the vacuum reservoir is battery powered.
[Form 56]
Forms 54-55, wherein the vacuum reservoir is in fluid communication with the sample notch and is configured to increase suction when cutting a tissue sample and/or maintain a vacuum level within the sample notch. The biopsy device according to claim 1.
[Form 57]
From Form 54, wherein the vacuum reservoir is in fluid communication with the interior of the inner member and is configured to provide a temporary boost of air flow to maintain a vacuum level when a tissue sample is drawn through the inner member. 56. The biopsy device according to any one of 56.
[Form 58]
The vacuum reservoir is in fluid communication with the tissue recovery tank and either provides a vacuum to the tissue recovery tank or transfers suction to the tissue recovery tank when transferring the tissue sample into the sample recovery tank from the sample notch or the like. 58. The biopsy device according to any of aspects 54-57, configured to augment.
[Form 59]
Form 1-58, further comprising a first actuator system and/or a transport mechanism for moving the toothed rack between the first advanced position and the second retracted position within the cutting cannula. The biopsy device according to claim 1.
[Form 60]
60. The biopsy device of form 59, wherein the first actuator system comprises a toothed wheel configured to engage the toothed rack.
[Form 61]
Any of features 1-60, further comprising a triggering mechanism for distally displacing the cutting cannula and the inner member longitudinally to penetrate body tissue at or near the suspicious mass of tissue. The biopsy device according to paragraph 1.
[Form 62]
The cutting mechanism includes a cannula actuator and a first position that exposes the sample notch at the proximal end of the sample notch for cutting the tissue sample from remaining body tissue at the collection site. 62. A cannula firing mechanism for longitudinally displacing the cutting cannula distally to a second position at the distal end of the notch. Biopsy device.
[Form 63]
63. The biopsy device of any one of Forms 1-62, wherein the inner member further comprises a vacuum port in fluid communication with the sample notch.
[Mode 64]
64. The biopsy device according to any one of Forms 1-63, wherein the inner member is configured to evacuate the sample notch.
[Form 65]
Form 1-64, further comprising a vacuum pump for creating a suction effect in the sample notch, the vacuum pump being in fluid communication with the sample notch through a longitudinally extending passage in the inner member. The biopsy device according to any one of the above.
[Form 66]
66. The biopsy device according to any one of Forms 1 to 65, wherein the cutting cannula is made primarily of stainless steel.
[Form 67]
67. The biopsy device according to any one of Forms 1 to 66, wherein the inner member is made primarily of stainless steel.
[Form 68]
68. The biopsy device of any one of Forms 1 to 67, wherein the biopsy device is handheld.
[Form 69]
It further comprises a handle unit comprising a power source for driving the cutting mechanism and for displacing the inner member and at least one motor, wherein the cutting cannula and the inner member are detachable from the handle unit. 69. The biopsy device of any one of Forms 1-68, contained within a disposable unit secured to.
[Form 70]
A first advanced position in which the toothed rack can be placed in a distal position with the sample notch of the toothed rack to cut the at least one tissue sample by the cutting mechanism; Further comprising a transport mechanism and/or a first actuator system for moving the toothed rack within the cutting cannula between a second retracted position for placement in a proximal position with a notch, the transport mechanism comprising: The biopsy device of any one of aspects 1 to 69, comprising a toothed wheel configured to be engaged with the toothed rack.
[Form 71]
A disposable unit for a biopsy device for taking at least one tissue sample from a suspicious tissue mass in the body of a living organism,
A hollow cutting cannula,
An inner member comprising a rigid toothed rack having a sharp distal tip configured to be introduced into the body and a sample notch for receiving the at least one cut tissue sample, said inner member comprising: An inner member that can be received within the cutting cannula;
A second position at a distal end of the sample notch from a first position exposing the sample notch at a proximal end of the sample notch for cutting the tissue sample from remaining body tissue at a collection site. To a position, and a cutting mechanism configured to displace the cutting cannula in the distal direction in the longitudinal direction.
[Form 72]
72. The disposable unit of form 71, further comprising any one of the features of forms 3, 20, 21 and 25-70.
[Form 73]
72. The disposable unit of form 71, wherein the rigid toothed rack is a rotatable toothed rack and further comprises any one of the features of forms 2-70.
[Form 74]
A method of taking at least one biopsy tissue sample from the body of a living organism, said method comprising:
Introducing a hollow cutting cannula with the distal end portion into the body to position the distal end portion near a suspicious mass of tissue, wherein the hollow needle has the cutting end at its distal end. A rigid toothed rack having a sample notch for receiving the at least one tissue sample, the rigid toothed rack having a distal end of the sample notch and a distal tip of the cutting cannula. Movable longitudinally within the cutting cannula between a first extended position projecting from the portion and a second retracted position proximal to the first position; ,
Activating a triggering mechanism for displacing the cutting cannula and the rigid toothed rack distally in the longitudinal direction, whereby the tip of the rigid toothed rack and the cutting cannula. A distal end portion penetrating the suspicious mass of tissue;
Retracting the cutting cannula to a first position where the sample notch projects from the distal end of the cutting cannula;
The cutting cannula in a distal direction in the longitudinal direction from a first position exposing the sample notch at the proximal end of the sample notch to a second position at the distal end of the sample notch. Activating a cutting mechanism to displace, whereby the tissue sample is cut from the remaining body tissue at the collection site;
Moving the rigid toothed rack within the cutting cannula to its second retracted position;
Withdrawing the first tissue sample from the sample notch when the rigid toothed rack is in its second retracted position.
[Form 75]
The method further comprises the step of simultaneously rotating the rigid toothed rack and the cutting cannula about their longitudinal axes with respect to a biopsy device, whereby the sample is preferably prior to activating the starting mechanism. The method of form 74, wherein a notch is directed toward the suspicious tissue mass.
[Form 76]
Form 74-75, further comprising the step of rotating the rigid toothed rack about its longitudinal axis relative to the cutting cannula when cutting a tissue sample to cut the attached tissue The method according to any one of 1.
[Form 77]
The rigid toothed rack is preferably continuous in small steps, preferably between 0.1 mm and 2 mm, with reference to the cutting cannula when cutting a tissue sample for the purpose of cutting the attached tissue. 77. The method of any one of features 74-76, further comprising retracting and advancing.
[Form 78]
Aspirating a tissue sample into the sample notch prior to cutting and/or
Form 74-77 further comprising the step of activating a vacuum reservoir to temporarily increase the negative air flow for the purpose of maintaining a vacuum level in connection with withdrawing a tissue sample from the sample notch. The method according to any one of the above.
[Form 79]
79. The method of any of aspects 74-78, wherein the method is performed by the biopsy device of any of aspects 1-70.

Claims (40)

A biopsy device for taking at least one tissue sample from a suspicious mass of tissue in the body of a living organism, comprising:
A hollow cutting cannula (1,1'),
A rotatable tooth having a sharp distal end (4, 4') adapted to be introduced into the body and a sample notch (3, 3') for receiving the at least one cut tissue sample. An inner member (2,3,4;2,3',4') including an attached rack that can be received within the cutting cannula (1,1'). 3', 4'),
The first position exposing the sample notch (3,3′) at the proximal end of the sample notch (3,3′) for cutting the tissue sample from remaining body tissue at the collection site. A cutting mechanism (13,3) configured to displace the cutting cannula (1,1') longitudinally distally to a second position at the distal end of the sample notch (3,3'). 14) and
When the cutting mechanism (13, 14) cuts a tissue sample, the distal end of the cutting cannula (1, 1') is temporarily moved to the sample notch (3) before returning to the second position. , 3') is passed over the distal end of the cutting mechanism (13, 14) is connected to the cutting cannula (1, 1') and the length of the passage is the cutting cannula (1, 1'). Biopsy, wherein the distal end of 1,1') passes temporarily beyond the distal end of the sample notch (3,3') before returning to the second position. device. The length of said passage is between 0.5 mm and 5 mm, between 0.5 mm and 1 mm, between 1 mm and 2 mm, between 2 mm and 3 mm, between 3 mm and 4 mm, or between 4 mm and 5 mm. The biopsy device according to claim 1 . The biopsy device according to any one of claims 1 to 2 , wherein the cutting mechanism comprises an elastic element connected to the cutting cannula and configured to perform the passage. The biopsy device of claim 3 , wherein the elastic element comprises at least one damper spring mounted within a damper spring housing. The biopsy device according to claim 3 , wherein the elastic element comprises at least one damping element formed of rubber. The biopsy device according to any one of claims 1 to 5 , wherein the cutting cannula comprises at least one longitudinal vacuum channel formed inside an outer shell of the cutting cannula. The cutting cannula (1, 1 ') comprises cutting cannula (1, 1' biopsy device according to configured claim 6 so as to provide a vacuum to the interior of). 8. The biopsy device according to any one of claims 6 to 7 , wherein the longitudinal vacuum channel is circumferential within the outer shell of the cutting cannula. It said longitudinal vacuum channel, at its proximal end, the passed outside the external fluid of the cutting cannula, the biopsy device according to any one of claims 6 to 8. The biopsy device according to claim 9 , wherein the external fluid communication is achieved by at least one vacuum spout and controlled by at least one vacuum valve. The biopsy device according to any one of claims 6 to 10 , wherein the longitudinal vacuum channel is in fluid communication at its distal end with the interior of the cutting cannula. 7. The longitudinal vacuum channel is in fluid communication with the sample notch at its distal end when the distal end of the cutting cannula (1,1') is in the second position. The biopsy device according to any one of items 11 to 11. Wherein fluid communication is achieved by the the internal longitudinal to vacuum channels (19) one extending or more lateral vents of the cutting cannula (1, 1 ') (20), claims 11 The biopsy device according to any one of claims 12 to 12. 14. The biopsy device of claim 13 , comprising a plurality of the lateral vents circumferentially distributed within the cutting cannula. Wherein it is transferred from the sample notch further comprising a tissue collecting tank for collecting the at least one tissue sample, biopsy device according to any one of claims 1 to 14. The biopsy device of claim 15 , wherein the tissue collection tank is configured to be evacuated. The tissue recovery tank (8) is configured to be evacuated to facilitate transfer of a tissue sample from the sample notch (3, 3') or the like into the tissue recovery tank (8) . The biopsy device according to any one of claims 15 to 16. 18. The biopsy device according to any one of claims 15 to 17 , wherein the tissue recovery tank further comprises a vacuum port for providing a vacuum inside the tissue recovery tank. The tissue collection tank (8) further comprises a collection pipe configured to transfer a tissue sample from the sample notch (3, 3') into the tissue collection tank (8) . The biopsy device according to any one of the above. 20. The biopsy device of claim 19 , wherein the recovery pipe extends to and/or projects into the tissue recovery tank. 21. The biopsy device according to any one of claims 19 to 20 , wherein the recovery pipe projects from a bottom or side inside the tissue recovery tank. 22. The biopsy device according to any one of claims 19 to 21 , wherein the recovery pipe has a length inside the tissue recovery tank. The length of the recovery pipe is at least 2 mm, at least 4 mm, at least 6 mm, at least 8 mm, at least 10 mm, at least 12 mm, at least 14 mm, at least 16 mm, at least 18 mm, at least 20 mm, at least 22 mm, at least 24 mm, at least 26 mm, at least 28 mm, 23. The biopsy device according to any one of claims 19 to 22 , which is at least 30 mm, at least 32 mm, at least 34 mm, at least 36 mm, at least 38 mm, or at least 40 mm. Further comprising a vacuum reservoir configured to store a certain amount of vacuum that can maintain a temporary vacuum levels found to be supplied and / or system as boost air flows, claims 1 to 23 The biopsy device according to claim 1. 25. The biopsy device of claim 24 , wherein the vacuum reservoir is battery powered. The vacuum reservoir is fluidly connected to the sample notch is configured to maintain a vacuum level and / or in said sample notch to increase the suction force when cutting the tissue sample 25 from claim 24 The biopsy device according to any one of the above. The vacuum reservoir is in fluid communication with the interior of the inner member, configured to provide temporary boost air flow to maintain the vacuum level when inhale tissue samples through the inner member, according to claim 24 A biopsy device according to any one of claims 26 to 26 . The vacuum reservoir is fluidly connected to the tissue collection tank (8), said sample notch (3,3 ') the tissue recovery tank when transferring the tissue sample into the tissue collection tank (8) in the like (8) A biopsy device according to any one of claims 24 to 27, which is configured to provide a vacuum to or increase the suction of the tissue recovery tank (8) . Further comprising a first actuator system and / or the transport mechanism for moving the toothed rack between said first position and said second position in the cutting cannula, claims 1 28 The biopsy device according to any one of the above. 30. The biopsy device of claim 29 , wherein the first actuator system comprises a toothed wheel configured to engage the toothed rack. Further comprising a start-up mechanism for the cause of the cutting cannula and the inner member is displaced distally in the longitudinal direction for penetrating at or near the body tissue of the suspect tissue mass, one of the Claims 1 to 30 The biopsy device according to 1 above. The cutting mechanism includes a cannula actuator and a first position that exposes the sample notch at the proximal end of the sample notch for cutting the tissue sample from remaining body tissue at the collection site. to a second position where the distal end of the notch, and a cannula starting mechanism for displacing the cutting cannula distally in the longitudinal direction, according to any one of claims 1 to 31 Biopsy device. The inner member further comprises a vacuum port in fluid communication with said sample notch biopsy device according to any one of claims 1 to 32. 34. The biopsy device of any one of claims 1-33, wherein the inner member is configured to evacuate the sample notch. The sample within the notch further comprises a vacuum pump for generating a suction effect, the vacuum pump is fluidly connected to said sample notch through a passageway extending longitudinally in said inner member, claim 1 Biopsy device according to any one of paragraphs 34 to 34 . The biopsy device according to any one of claims 1 to 35 , wherein the cutting cannula is mainly made of stainless steel. 37. The biopsy device according to any one of claims 1 to 36 , wherein the inner member is made primarily of stainless steel. The biopsy device is that a handheld biopsy device according to any one of claims 1 to 37. It further comprises a handle unit comprising a power source for driving the cutting mechanism and for displacing the inner member and at least one motor, wherein the cutting cannula and the inner member are detachable from the handle unit. 39. A biopsy device according to any one of claims 1 to 38 contained within a disposable unit secured to. A first advanced position in which the toothed rack can be placed in a distal position with the sample notch of the toothed rack to cut the at least one tissue sample by the cutting mechanism; Further comprising a transport mechanism and/or a first actuator system for moving the toothed rack within the cutting cannula between a second retracted position for placement in a proximal position with a notch, the transport mechanism comprising: 40. The biopsy device of any one of claims 1-39 , comprising a toothed wheel configured to be engaged with the toothed rack.

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